Japan's PAFSC puts off decision on new Xarelto indication approval

SINGAPORE--A decision on whether to recommend approval of an additional indication for Bayer Yakuhin's anticoagulant Xarelto (rivaroxaban) has been put on hold by Japan's Pharmaceutical Affairs and Food Sanitation Council, an advisory committee, following a meeting on Feb. 20, according to a news release.

Deliberations center on whether Xarelto's indications should be expanded to include the treatment and relapse prevention of deep vein thrombosis and pulmonary embolism. The committee reports to the Ministry of Health, Labour and Welfare (MHLW) and did not respond to a request for elaboration.

However, the committee supported marketing authorization and approval of Actelion Pharmaceuticals Japan's macitentan, which was jointly developed with Nippon Shinyaku, for the treatment of pulmonary arterial hypertension.

Genzyme Japan's eliglustat tartrate was also approved, which would make it the first oral medicine for Gaucher's disease in Japan.